Brain & Muscle Stimulation for Stroke Rehabilitation

Overseen By David A Cunningham, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: MetroHealth Medical Center

Must not be taking: Seizure medications

Disqualifiers: Neurological conditions, Seizure disorder, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 6 weeks

15 Participants Needed

Trial Summary

What is the purpose of this trial?

This pilot study for stroke patients with chronic upper limb hemiplegia will examine the effects of non-invasive brain stimulation and neuromuscular electrical stimulation on hand motor control and corticospinal excitability. Specifically, this study will investigate the effects of timing and delivery of tDCS in conjunction with contralaterally controlled functional electrical stimulation.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using medications that lower the seizure threshold, as decided by the study physician.

What data supports the effectiveness of this treatment for stroke rehabilitation?

Research shows that transcranial direct current stimulation (tDCS), a non-invasive brain stimulation technique, is associated with significant motor function improvement in stroke patients, especially when used in repeated sessions. ^{1 2 3 4 5}

Is transcranial direct current stimulation (tDCS) safe for humans?

Transcranial direct current stimulation (tDCS) is generally considered safe for humans when used at an intensity of 4 mA or less for up to 60 minutes per day, with no severe complications reported in over 33,200 sessions. However, it can cause mild skin irritation, and caution is advised for potentially vulnerable groups like children and the elderly. ^{6 7 8 9 10}

How is the treatment 'Brain & Muscle Stimulation for Stroke Rehabilitation' different from other stroke rehabilitation treatments?

This treatment uses transcranial direct current stimulation (tDCS), a non-invasive method that applies a small electrical current to the brain to enhance motor recovery and improve daily living activities after a stroke, which is different from traditional physical therapies that do not involve direct brain stimulation. ^{5 11 12 13 14}

Research Team

David A Cunningham, PhD

Principal Investigator

MetroHealth Medical Center

Eligibility Criteria

This trial is for stroke survivors over 21 years old with chronic upper limb hemiplegia, who can follow commands and have some finger movement. They must be medically stable, able to sit unassisted, and at least 6 months post-stroke. Excluded are pregnant individuals, those with other neurological conditions or severe pain in the affected limb, recent botox injections in the arm muscles, certain metal implants or electronic devices.

Inclusion Criteria

I can fully move and use my unaffected arm and hand.

I can follow complex instructions and remember things well.

Medically stable

Exclusion Criteria

I cannot move my hand or shoulder without severe pain.

I have seizures that are not controlled by medication.

I have a neurological condition besides a past stroke affecting my arm.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive non-invasive brain stimulation and neuromuscular electrical stimulation to improve hand motor control

6 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• electrical stimulator
• transcranial direct current stimulation

Trial Overview The study tests how non-invasive brain stimulation (tDCS) combined with functional electrical stimulation affects hand motor control in stroke patients. It explores optimal timing and delivery methods of these treatments to improve hand function.

Participant Groups

Group I: unconventional tDCS preceding CCFES Experimental Treatment 1 Intervention

tDCS cathode placed over the lesioned hemisphere and anode placed over the non-lesioned hemisphere

Group II: unconventional tDCS concurrent with CCFES Experimental Treatment 1 Intervention

tDCS cathode placed over the lesioned hemisphere and anode placed over the non-lesioned hemisphere

Group III: conventional tDCS preceding CCFES Experimental Treatment 1 Intervention

tDCS anode placed over the lesioned hemisphere and cathode placed over the non-lesioned hemisphere

Group IV: conventional tDCS concurrent with CCFES Experimental Treatment 1 Intervention

tDCS anode placed over the lesioned hemisphere and cathode placed over the non-lesioned hemisphere

Group V: sham tDCS with CCFES Placebo Group 1 Intervention

sham tDCS preceding and concurrent with CCFES

electrical stimulator is already approved in United States, European Union for the following indications:

Approved in United States as Transcranial Direct Current Stimulation (tDCS) for:

• Stroke rehabilitation
• Motor disorders

Approved in European Union as Transcranial Direct Current Stimulation (tDCS) for:

• Stroke rehabilitation
• Motor disorders

Who Is Running the Clinical Trial?

MetroHealth Medical Center

Lead Sponsor

Trials

125

Recruited

22,600+

Findings from Research

In a study involving 10 chronic stroke patients, bihemispheric transcranial direct current stimulation (tDCS) combined with therapy led to significant improvements in motor function, with an average increase of 8.2 points on the Upper-Extremity Fugl-Meyer scale after two 5-day treatment periods.

The first treatment period showed a larger improvement (5.9 points) compared to the second period (2.3 points), indicating that while tDCS is effective, the benefits from multiple sessions may not increase linearly, which is important for future rehabilitation studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined central and peripheral stimulation to facilitate motor recovery after stroke: the effect of number of sessions on outcome. Lindenberg, R., Zhu, LL., Schlaug, G.[2021]

Transcranial direct current stimulation (tDCS) significantly improves motor function in stroke patients, with notable effects from both cathodal stimulation of the unaffected hemisphere and anodal stimulation of the affected hemisphere, as shown in a study involving multiple sessions and a blinded evaluation.

Consecutive daily sessions of tDCS resulted in lasting improvements in motor function for up to two weeks after treatment, suggesting that this simple and safe technique could be an effective rehabilitation tool for stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repeated sessions of noninvasive brain DC stimulation is associated with motor function improvement in stroke patients. Boggio, PS., Nunes, A., Rigonatti, SP., et al.[2022]

Transcranial direct current stimulation (TDCS) is a noninvasive brain stimulation technique that can help in understanding brain function and may aid in the recovery of patients after a stroke.

TDCS has the potential to enhance neuroplasticity, which is crucial for stroke recovery, by modulating brain activity and facilitating rehabilitation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation in stroke recovery. Schlaug, G., Renga, V., Nair, D.[2022]

Transcranial direct current stimulation (tDCS) significantly improves motor recovery in stroke patients, with effect sizes of 0.26 for upper limb and 0.47 for lower limb functions based on a meta-analysis of 29 studies involving 664 subjects.

Chronic stroke patients showed notable improvements in upper limb function after tDCS, while subacute stroke patients experienced more significant benefits for lower limb function, indicating that the timing and parameters of tDCS treatment are crucial for optimizing recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Different Therapeutic Effects of Transcranial Direct Current Stimulation on Upper and Lower Limb Recovery of Stroke Patients with Motor Dysfunction: A Meta-Analysis. Bai, X., Guo, Z., He, L., et al.[2020]

The study involved 49 subacute stroke patients who participated in a 4-week robotic gait training program combined with transcranial direct current stimulation (tDCS), demonstrating that this combined approach is safe and feasible, with only one patient experiencing a minor side effect.

Despite improvements in gait speed and quality across all groups, the addition of tDCS targeting the leg motor cortex did not provide any additional benefits compared to robotic gait training alone or tDCS targeting the hand motor cortex.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

tDCS does not enhance the effects of robot-assisted gait training in patients with subacute stroke. Leon, D., Cortes, M., Elder, J., et al.[2018]

Transcranial Direct Current Stimulation (tDCS) has been shown to be safe, with no reports of Serious Adverse Effects or irreversible injuries across over 33,200 sessions involving more than 1,000 subjects, including vulnerable populations.

Safety assessments indicate that the current densities used in conventional tDCS (≤4 milliamperes) are significantly lower than those that could potentially cause brain injury, suggesting that tDCS protocols are well within safe limits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Bikson, M., Grossman, P., Thomas, C., et al.[2022]

Transcranial direct current stimulation (tDCS) has been found to be safe for use in humans, with no severe complications reported in studies involving both adults and children when applied at intensities of 4 mA or less for up to 60 minutes.

Animal studies indicate that the electrical current used in tDCS is significantly lower than the threshold that could cause permanent changes to brain tissue, suggesting a strong safety profile for this neurorehabilitation method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation in Neurorehabilitation. Ko, MH.[2023]

Microdermabrasion significantly reduced skin resistance by about 32%, allowing for higher doses of transcranial direct current stimulation (tDCS) without increasing skin sensations or device limitations.

The study found that while microdermabrasion increased perceived sensations slightly when not combined with sonication, overall, it enabled safer and more effective delivery of tDCS by lowering the voltage needed to achieve the same current.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microdermabrasion facilitates direct current stimulation by lowering skin resistance. Chhatbar, PY., Liu, S., Ramakrishnan, V., et al.[2023]

Transcranial Direct Current Stimulation (tDCS) is generally considered safe, but there are concerns that it could lead to significant negative effects in healthy individuals.

The scientific community needs to be alerted about the potential risks of tDCS, emphasizing the importance of protecting healthy volunteers from possible harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of transcranial direct current stimulation in healthy participants. Boccard-Binet, S., Sen, A.[2021]

A study involving 24 rats showed that 500 μA cathodal transcranial direct current stimulation (tDCS) applied for 10 days was safe, with no adverse effects on motor functions, learning, or memory.

The treatment did not cause any significant changes in brain morphology, neurotransmitter levels, or overall organ health, indicating that this level of tDCS is safe for use in research settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A safety study of 500 μA cathodal transcranial direct current stimulation in rat. Zhang, K., Guo, L., Zhang, J., et al.[2020]

Transcranial direct current stimulation (tDCS) using a new montage improved the detection of right-hand motor imagery in 4 out of 5 healthy volunteers when applied for 10 minutes at the highest current density over the right-hand motor area.

While changes in EEG band power were not directly linked to improved classification accuracy, the study suggests that tDCS can influence different motor areas, indicating potential for enhancing motor neurorehabilitation techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of tDCS stimulation of motor cortex and cerebellum on EEG classification of motor imagery and sensorimotor band power. Angulo-Sherman, IN., Rodríguez-Ugarte, M., Sciacca, N., et al.[2018]

Transcranial direct current stimulation (tDCS) shows some potential in improving activities of daily living (ADLs) in stroke survivors, with a moderate effect size observed in a systematic review of 32 studies involving 748 participants.

However, the evidence for tDCS's effectiveness on upper extremity function and muscle strength is weak, and many ongoing trials may provide more clarity on its benefits in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Elsner, B., Kugler, J., Pohl, M., et al.[2023]

Transcranial direct current stimulation (tDCS) shows potential in enhancing rehabilitation and improving motor function after a stroke, likely by correcting imbalances in brain activity between the two hemispheres.

While recent trials have shown promising results, more research is needed to establish the best stimulation methods before tDCS can be officially recommended for stroke recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Non-invasive direct current stimulation of the brain: a new technique for stroke rehabilitation]. Figlewski, K., Andersen, H.[2018]

Transcranial direct current stimulation (tDCS) effectively increases beta-frequency power in the brain, indicating a readiness for improved cognitive functioning, as observed in a study with 10 healthy participants.

This study is significant as it is the first to simultaneously apply tDCS while recording EEG, providing insights into the dynamic changes in brain activity during stimulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beta-frequency EEG activity increased during transcranial direct current stimulation. Song, M., Shin, Y., Yun, K.[2014]

References

1. United States pubmed.ncbi.nlm.nih.gov

Combined central and peripheral stimulation to facilitate motor recovery after stroke: the effect of number of sessions on outcome. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Repeated sessions of noninvasive brain DC stimulation is associated with motor function improvement in stroke patients. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation in stroke recovery. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Different Therapeutic Effects of Transcranial Direct Current Stimulation on Upper and Lower Limb Recovery of Stroke Patients with Motor Dysfunction: A Meta-Analysis. [2020]

5. Netherlands pubmed.ncbi.nlm.nih.gov

tDCS does not enhance the effects of robot-assisted gait training in patients with subacute stroke. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. [2022]

7. Korea (South) pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation in Neurorehabilitation. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Microdermabrasion facilitates direct current stimulation by lowering skin resistance. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Safety of transcranial direct current stimulation in healthy participants. [2021]

10. England pubmed.ncbi.nlm.nih.gov

A safety study of 500 μA cathodal transcranial direct current stimulation in rat. [2020]

11. England pubmed.ncbi.nlm.nih.gov

Effect of tDCS stimulation of motor cortex and cerebellum on EEG classification of motor imagery and sensorimotor band power. [2018]

12. England pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. [2023]

13. Denmark pubmed.ncbi.nlm.nih.gov

[Non-invasive direct current stimulation of the brain: a new technique for stroke rehabilitation]. [2018]

14. England pubmed.ncbi.nlm.nih.gov

Beta-frequency EEG activity increased during transcranial direct current stimulation. [2014]